L Chebane1, H Bagheri2, D Hillaire-Buys3, H Géniaux4, N Yahioui5, M-L Laroche6, J Cottin7, A Spreux8, B Mosquet9, C Pecriaux10, F Bellet11, A Lambert12, J-L Montastruc1. 1. Laboratoire de pharmacologie médicale et clinique, centre de Midi-Pyrénées de pharmacovigilance, de pharmaco-épidémiologie et d'informations sur le médicament, équipe de pharmaco-épidémiologie de l'UMR, Inserm U1027, CHU de Toulouse, faculté de médecine, université de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France. 2. Laboratoire de pharmacologie médicale et clinique, centre de Midi-Pyrénées de pharmacovigilance, de pharmaco-épidémiologie et d'informations sur le médicament, équipe de pharmaco-épidémiologie de l'UMR, Inserm U1027, CHU de Toulouse, faculté de médecine, université de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France. Electronic address: haleh.bagheri@univ-tlse3.fr. 3. Centre régional de pharmacovigilance de Montpellier, 34295 Montpellier cedex 5, France. 4. Centre régional de pharmacovigilance de Bordeaux, 33076 Bordeaux cedex, France. 5. Centre régional de pharmacovigilance de Grenoble, 38043 Grenoble cedex, France. 6. Centre régional de pharmacovigilance de Limoges, 87042 Limoges cedex, France. 7. Centre régional de pharmacovigilance de Lyon, 69424 Lyon cedex 3, France. 8. Centre régional de pharmacovigilance de Nice, 06003 Nice cedex 1, France. 9. Centre régional de pharmacovigilance de Caen, 14033 Caen cedex 9, France. 10. Centre de pharmacovigilance de Paris Cochin, 75014 Paris, France. 11. Centre régional de pharmacovigilance de St-Étienne, 42055 Saint-Étienne cedex 02, France. 12. Centre régional de pharmacovigilance de Strasbourg, 67091 Strasbourg cedex, France.
Abstract
PURPOSE: Identify the main pharmacological classes inducing pancreatitis using spontaneous reports recorded in the French pharmacovigilance database (FPVD). METHODS: Cases of pancreatitis recorded in FPVD between January 1st 1985 and December 31st 2013 were selected using the 2001 consensus conference criteria of the French High Health Authority. RESULTS: During this period, 2975 observations were selected with 1151 fulfilling criteria of drug-induced pancreatitis (i.e. 0.22% of total notifications in the FPVD). According to ATC classification, the pharmacological classes most frequently found were antiretroviral, analgesic, lipid-lowering, immunosuppressive and insulin secreting drugs. For some drugs (metformin, omeprazole, etc.) pancreatitis was "unlabelled" in the summary of product characteristics. CONCLUSION: This review allows to identify the main drug classes currently involved in spontaneous reporting of pancreatitis in France.
PURPOSE: Identify the main pharmacological classes inducing pancreatitis using spontaneous reports recorded in the French pharmacovigilance database (FPVD). METHODS: Cases of pancreatitis recorded in FPVD between January 1st 1985 and December 31st 2013 were selected using the 2001 consensus conference criteria of the French High Health Authority. RESULTS: During this period, 2975 observations were selected with 1151 fulfilling criteria of drug-induced pancreatitis (i.e. 0.22% of total notifications in the FPVD). According to ATC classification, the pharmacological classes most frequently found were antiretroviral, analgesic, lipid-lowering, immunosuppressive and insulin secreting drugs. For some drugs (metformin, omeprazole, etc.) pancreatitis was "unlabelled" in the summary of product characteristics. CONCLUSION: This review allows to identify the main drug classes currently involved in spontaneous reporting of pancreatitis in France.